HealthyPhase 1TDE-PH-125NCT02318758
Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers
A Phase 1 study testing UT-15C and ethanol in people with Healthy, run by United Therapeutics at 1 site in United States.
Trial summary
A study to assess the interaction of acohol and oral treprostinil. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- UT-15C and ethanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject voluntarily gives informed consent to participate in the study.
- Women of child bearing potential includes any female who has experienced menarche and who has not undergone successful surgical sterilization. Women of childbearing potential must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception for the duration of the study, and for at least 30 days after discontinuing study medication. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptives (such as birth control pills), (2) barrier methods used with a spermicide, (3) an intrauterine device, or (4) partner vasectomy. For women of childbearing potential, a negative urine pregnancy test is required at Screening and Baseline prior to initiating study medication.
- The subject, if male, must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication.
- Healthy male and female subjects aged 21-55 years of age at the time of signing the informed consent.
- Weight between 55 and 100 kg, with a BMI between 19.0-29.9 kg/m2, inclusive for female subjects and weight between 55 and 120 kg, with a BMI between 19.0-32.0 kg/m2, inclusive for male subjects.
- Regular consumption of ethanol with no recent changes in pattern of consumption
- In the opinion of the Principal Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits.
Who cannot join
- The subject is pregnant or lactating.
- Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
- Subject has a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- Subject has a history of postural hypotension, or unexplained syncope.
- Subject has a blood pressure that is less than 85 mmHg systolic or 50 mmHg diastolic at Screening or Baseline.
Show all 17Show fewer
- Subject has a pulse rate that is greater than 90 bpm after sitting at rest for 5 minutes at Screening or Baseline.
- Subject has a blood pressure that is greater than 150 mmHg systolic or 90 mmHg diastolic at Screening or Baseline.
- Subject has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subject has tested positive at the screening visit for HIV infection, HBsAg, or the HCV antibody.
- Subject currently uses tobacco products or has a history of tobacco use within two months prior to Baseline.
- Subject has a history of ethanol abuse or a history of or current impairment of organ function reasonably related to ethanol abuse.
- Subject has a history of or current evidence of abuse of licit or illicit drugs, including a positive urine screen for drugs of abuse at Screening or Baseline.
- Subject has a history of abnormal bleeding tendencies.
- Subject has donated blood or plasma or has lost a significant volume of blood within four weeks prior to Baseline.
- Subject has clinically significant abnormal laboratory values in the opinion of the treating Investigator.
- Subject has participated in a research study within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single Dose, 4-Way Cross-over Study to Investigate the Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers
A study to assess the interaction of acohol and oral treprostinil.
Read the detailed description
This study will compare the effects of ethanol on the PKs of a 1 mg dose of UT-15C in healthy volunteers to determine the in vivo effects of ethanol, including the timing of ethanol consumption in relation to UT-15C ingestion.
This is an open-label, randomized, single-center, four-way (period), crossover study in which 28 healthy volunteers will receive a single 1 mg oral dose of UT-15C and/or ethanol. Eligible subjects will be randomly assigned to one of four treatment sequences such that all subjects will receive all four sequences in a pre-specified order.
- Conditions
- Healthy
- Being tested
- UT-15C, ethanol
- Keywords
- This is a healthy volunteer study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UT-15CDrug
Also called Oral treprostinil
sustained release oral treprostinil
ethanolOther
Also called alcohol
Absolut 100 vodka
| Study group | Role | What they receive |
|---|---|---|
| Comparison 1 | Active comparator | UT-15C 1 mg alone Receives: Drug: UT-15C |
| Comparison 2 | Active comparator | UT-15C 1 mg plus ethanol (simultaneously) Receives: Drug: UT-15C; Other: ethanol |
| Comparison 3 | Active comparator | UT-15C 1 mg administered 1 hour before ethanol Receives: Drug: UT-15C; Other: ethanol |
| Comparison 4 | Active comparator | UT-15C 1 mg administered 1 hour after ethanol Receives: Drug: UT-15C; Other: ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of oral treprostinil (Cmax)
Measured: Subjects will be enrolled for 24 days
Secondary outcomes (1)
Safety and tolerability via laboratory values, collection of adverse events, vital signs and electrocardiogram.
Measured: Subjects will be enrolled for 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aziz Laurent, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318758
- Sponsor's protocol ID
- TDE-PH-125
- Acronym
- TDE-PH-125
- Status last verified
- Dec 2014
- First submitted
- 15 Sep 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single Dose, 4-Way Cross-over Study to Investigate the Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02318758
- Acronym / sponsor ID
- TDE-PH-125 / TDE-PH-125
- Conditions
- Healthy
- Keywords
- This is a healthy volunteer study.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the interaction of acohol and oral treprostinil.
Detailed description
This study will compare the effects of ethanol on the PKs of a 1 mg dose of UT-15C in healthy volunteers to determine the in vivo effects of ethanol, including the timing of ethanol consumption in relation to UT-15C ingestion.
This is an open-label, randomized, single-center, four-way (period), crossover study in which 28 healthy volunteers will receive a single 1 mg oral dose of UT-15C and/or ethanol. Eligible subjects will be randomly assigned to one of four treatment sequences such that all subjects will receive all four sequences in a pre-specified order.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Comparison 1 | Active comparator | Drug: UT-15CUT-15C 1 mg alone |
| Comparison 2 | Active comparator | Drug: UT-15C, Other: ethanolUT-15C 1 mg plus ethanol (simultaneously) |
| Comparison 3 | Active comparator | Drug: UT-15C, Other: ethanolUT-15C 1 mg administered 1 hour before ethanol |
| Comparison 4 | Active comparator | Drug: UT-15C, Other: ethanolUT-15C 1 mg administered 1 hour after ethanol |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject voluntarily gives informed consent to participate in the study.
- Women of child bearing potential includes any female who has experienced menarche and who has not undergone successful surgical sterilization. Women of childbearing potential must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception for the duration of the study, and for at least 30 days after discontinuing study medication. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptives (such as birth control pills), (2) barrier methods used with a spermicide, (3) an intrauterine device, or (4) partner vasectomy. For women of childbearing potential, a negative urine pregnancy test is required at Screening and Baseline prior to initiating study medication.
- The subject, if male, must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication.
- Healthy male and female subjects aged 21-55 years of age at the time of signing the informed consent.
- Weight between 55 and 100 kg, with a BMI between 19.0-29.9 kg/m2, inclusive for female subjects and weight between 55 and 120 kg, with a BMI between 19.0-32.0 kg/m2, inclusive for male subjects.
Key exclusion criteria (17 listed)
- The subject is pregnant or lactating.
- Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
- Subject has a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
- Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
- Subject has a history of postural hypotension, or unexplained syncope.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UT-15CAlso: Oral treprostinilsustained release oral treprostinil | Drug | Comparison 1, Comparison 2, Comparison 3, Comparison 4 |
| ethanolAlso: alcoholAbsolut 100 vodka | Other | Comparison 2, Comparison 3, Comparison 4 |
Primary outcome
Pharmacokinetics (PK) of oral treprostinil (Cmax)
Time frame: Subjects will be enrolled for 24 days
1 secondary outcome
Safety and tolerability via laboratory values, collection of adverse events, vital signs and electrocardiogram.
Time frame: Subjects will be enrolled for 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aziz Laurent, MD principal investigator
PPD Development, LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UT-15C and ethanol in people with Healthy, run by United Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of oral treprostinil (Cmax) (time frame: Subjects will be enrolled for 24 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.